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EU Industry Says Real Work Starts Now On Regulations

Industry recognizes considerable work has been done on cleaning up the texts of EU's future Medical Device and IVD Regulations. But it emphasized that further work is needed in the implementation phase to bring legal certainty and clarification.

Regulation Medical Device Europe

Russian Medtech Industry Wants Quicker Progress On Eurasian Bloc Plans – 2017 Now Targeted

The much-anticipated Eurasian Economic Union (EAEU) was originally targeted to come into effect at the start of 2016, but more than year later, the five-member trading bloc has yet to be ratified by all nations. The Russian medtech industry is impatient for progress, but IMEDA's Sergey Kolosov sees some promising signs in recent developments.

Russian Federation Regulation Medical Device

Device Debuts: Medtronic, Boston Scientific, Philips, Seventh Sense, Vortex, 410 Medical

Device Debuts is a new regular feature highlighting Medtech Insight editors’ top picks of medical devices that have been commercialized for the first time in the last month. This edition features an innovative minimally invasive surgical stapler, a pain-free blood-collection device, a novel approach for collecting, circulating tumor cells, a rapid fluid-infusion device for critically ill patients, and an EP-mapping and navigation system.

Surgery Cardiology Diagnostic Imaging

Compliance 360° Part 4: How To Better Manage Your Quality Data

This is Compliance 360°, an eight-part podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this fourth installment, former FDA investigations branch director Ricki Chase explains how your firm can better manage its quality data.

Quality Control Compliance Quality
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Policy & Regulation Explore this Topic

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New EU Regulations: Guide To Latest – Likely Final – Texts

Why are there so many more pages and articles in the latest, likely final, versions of the Medical Devices Regulation and the IVD Regulation compared to the 2016 versions? What do these changes mean for the regulations, which are due to be adopted imminently?

Regulation Medical Device Europe

US FDA Advisory Panel Backs Claret’s Sentinel TAVR Filter

The panelists said the agency should approve the filter, which is used to protect the brain during transcatheter aortic heart-valve replacement surgery, despite ongoing questions about its effectiveness.

Cardiology Advisory Committees Medical Device

Leap In US Sales Of IUDs Linked To Trump Election, ACA Repeal Efforts

Sales of contraceptive intrauterine devices rose in the 4th quarter of 2016 at some companies. The increase in interest in IUDs coincides with efforts to repeal Obamacare and eliminate contraceptive coverage guarantees, according to Planned Parenthood and AthenaHealth.

Gynecology & Urology Reimbursement

Brexit Podcast: Next Steps For The UK Medtech Industry

Ashley Yeo talks to Association of British Healthcare Industries' Nishan Sunthares and Richard Phillips about the subject that will dominate the thoughts, behavior and business of medical technology companies in the UK for many years to come.

Brexit United Kingdom

More Tweaking Of EU Regulations ‘Unlikely’ As Latest Texts Are Issued

The Council of the European Union published the latest versions of the Medical Device and IVD Regulations, and the timelines to full implementation are now clearer.

Europe Regulation

Class I Recall on Zimmer Biomet Shoulder Replacement

The recall involves 3,662 artificial shoulders manufactured between 2008 and 2011, which have a higher fracture risk than depicted in labeling.

Orthopedics Recalls

Warning Letter Roundup & Recap – Feb. 21, 2017

No device-related warning letters were released by US FDA the week of Feb. 21.

Device Warning Letters Regulation

EU Notified Bodies Prepare For En Masse Redesignation

Members of the TEAM-NB association, which account for about half of the anticipated future force of EU medtech notified bodies, are taking a coordinated approach to applying for redesignations against the new EU Medical Device and IVD Regulations. Will they succeed?

Regulation Europe

Quality Control Explore this Topic

Set Alert for Quality Control

EU Notified Bodies Prepare For En Masse Redesignation

Members of the TEAM-NB association, which account for about half of the anticipated future force of EU medtech notified bodies, are taking a coordinated approach to applying for redesignations against the new EU Medical Device and IVD Regulations. Will they succeed?

Regulation Europe

Compliance 360° Part 3: Building Trust With US FDA – Can It Be Done?

This is Compliance 360°, an eight-part podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this third installment, former FDA investigations branch director Ricki Chase explains how your firm can build trust with agency investigators during a facility inspection.

Quality Control Compliance

New Bill Aims To Bring Consistency, Transparency To US FDA Inspections

US Sens. Johnny Isakson, R-Ga., and Michael Bennet, D-Colo., introduced legislation that calls for adopting a uniform FDA inspection process to ensure parity between audits of foreign and domestic device firms, notifying manufacturers in advance of records that will be requested during an inspection, and specifying a window of time for investigators to conduct their onsite inspections, among other requirements.

Regulation Policy

Commercial Explore this Topic

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US Supreme Court Sides With Thermo Fisher In Diagnostics Patent Spat

The justices struck down an appeals court ruling that a single device component could count as a “substantial portion” under patent infringement laws.

Legal Issues Intellectual Property Commercial

Latest From Commercial

Leap In US Sales Of IUDs Linked To Trump Election, ACA Repeal Efforts

Sales of contraceptive intrauterine devices rose in the 4th quarter of 2016 at some companies. The increase in interest in IUDs coincides with efforts to repeal Obamacare and eliminate contraceptive coverage guarantees, according to Planned Parenthood and AthenaHealth.

Gynecology & Urology Reimbursement

Device Week – February, 24, 2017

On this week's Medtech Insight podcast: the response by a US FDA advisory panel to Claret Medical's de novo submission for the first brain-filter device intended to protect patients undergoing transcatheter aortic heart-valve replacement; a reporting trip to the Israeli innovation hub; a Boston Scientific recall; and bariatric surgery data.

Device Week Metabolic

Earnings Winners & Losers: MMSI, STMN, WMGI, RWLK, EXAS

As the earnings season continues, Medtech Insight takes a look at dental firm Straumann’s performance, as well as that of some mid- to small-cap companies – including extremities implant specialist Wright Medical – highlighting which we believe to be the season’s winners and losers.

Sales & Earnings Companies

Boston Scientific Pulls All Lotus TAVR Systems Off Shelves

The worldwide voluntary removal comes in response to reports that the pin that connects the valve to the delivery system sometimes releases prematurely, most likely due to excess tension created during manufacturing.

Cardiology Recalls

Russia's Medtech Looks For Chain Reaction After Philips Partnership Deal

Russia's health care sector has been under strain, suffering budgets cuts and repercussions from the ongoing sanctions. In the midst of this, plans to reinforce the local medtech industry received a boost recently when global top 10 manufacturer Philips Healthcare committed funds to embarking on new R&D locally and to further partnerships in Russia.

Russian Federation Market Access

First TAVR Filter To Reach FDA Panel Will Get Questions On Missed Endpoint

Claret Medical’s Sentinel embolic protection device for transcatheter aortic valve replacement is set to go before US FDA’s Circulatory System Devices Panel on Feb. 23. Trials found the de novo device is safe, but the agency has some concerns that a primary efficacy endpoint was missed.

Cardiology Neurology

Clinical R&D Explore this Topic

Set Alert for Clinical R&D

Ethicon-Sponsored Trial Shows Bariatric Surgery Improves Diabetics’ Outcomes

The final five-year results from the STAMPEDE trial, said to be the first randomized controlled trial in the bariatric space, show that bariatric surgery plus intensive medical therapy is more effective than intensive medical therapy alone in combating hyperglycemia in obese patients with type 2 diabetes.

Diabetic Care Surgery Clinical Trials

Latest From Research & Development

Intensix Data Analytics Demo High Accuracy In ICU Sepsis Detection

An analytics platform developed by Israeli big data company Intensix has shown high accuracy for detecting and predicting sepsis in critical care. The positive results were presented at the Healthcare Information and Management Systems Society (HIMSS) healthcare IT conference in Orlando, Florida.

Digital Health StartUps and SMEs

Starts & Stops: Abbott's Inherited Products Add To Spike In Suspensions

Starts & Stops is a regular feature highlighting Medtech Insight editors' picks of noteworthy medtech clinical trial initiations, completions and suspensions each month. This edition highlights an apparent trial-suspension spike in the past month, including three studies that were stopped by Abbott evaluating products it inherited from its acquisition of St Jude Medical.

Clinical Trials Research & Development

OUS Approvals Analysis: Medtronic, Abbott, Abionic Lead 2017 Upswing

The 20 non-US medical device approvals in January, including eight in in vitro diagnostics, four in orthopedics, and three in cardiovascular devices. Big medtech players Medtronic and Abbott, accompanied by much smaller Swiss IVD firm Abionic, led the charge and bagged more OUS approvals than most.

Approvals Research & Development

US Approvals Analysis: Slow 510(k) Month Includes Major Cardiac Assay Clearance

The number of 510(k) clearances in January by US FDA were lower than average, but there was at least one practice-changing advance deemed substantially equivalent last month: Roche's high-sensitivity Elecsys cardiac troponin assay. There were four original PMAs approved in January, but a lower-than-usual total of supplement approvals.

Approvals Innovation

Abbott Finally Joins MRI-Compatibility Club In US CRM Market

The firm’s Assurity MRI pacemaker and Tendril MRI pacing lead, acquired in its recent St. Jude Medical deal, gained US FDA approval after some delay. Lack of this designation has been a competitive challenge for the business in the past year.

Cardiology Approvals

Start-Up Spotlight: Bio2 Technologies Inc., Space-Tech Biomaterial For Extremities Surgery

Originating from aerospace technology, Bio2 Technologies’ Vitrium biomaterial platform is designed for multiple applications across musculoskeletal surgery. The firm has already begun commercialization in the US and expects to get a CE mark later this year.

Orthopedics StartUps and SMEs
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